NCT06325046Recruiting
Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- First submitted
- 15 Mar 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT06325046
What you commit to
- Study type: Interventional
- Planned participants: 164
- From 15 Aug 2024 to the primary completion date, 30 Apr 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
- Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
- Concurrent antineoplastic agents (chemotherapy)
- Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
Other illness
- NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
- Metastatic disease by conventional or molecular imaging
- Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
- Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
- Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
Other
- Prostate gland volume \> 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score \> 17
- Body weight \> 200 kilogram
Who the study is looking for
- Gender assigned male at birth: age ≥ 18 years
- Histological confirmation of prostate adenocarcinoma
- National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to complete questionnaire(s) by themselves or with assistance
- Signed informed consent
- Willing to complete requirements for follow-up (during active monitoring phase)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Health System in Albert Lea Coordinator of this site? Confirm its status | Albert Lea | United States | Recruiting |
| Mayo Clinic Health System-Eau Claire Coordinator of this site? Confirm its status | Eau Claire | United States | Recruiting |
| Mayo Clinic Health System-Franciscan Healthcare Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| Mayo Clinic Health System Mankato Coordinator of this site? Confirm its status | Mankato | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.